Considerations for the planning and conduct of reproducibility studies of in vitro diagnostic tests for infectious agents.

Abstract

The US Food and Drug Administration (FDA) requires reproducibility studies for premarket approval of in vitro diagnostic (IVD) tests. Results of reproducibility studies provide an estimate of the variability of the IVD test among study sites, reagent lots, site operators, within a single test run, and over multiple test days. In planning the study, discuss the product registration strategy, including the intended use of the product and desired label claims, and define the study team. Design the sample panel according to the limit of detection or quantitation of the test, dynamic range of the test, FDA guidelines, sample matrix, and genotype. Consider legal and ethical issues for obtaining the panel parent specimen, such as minimizing the privacy risk and keeping promises to donors. During the study, review data promptly to determine invalid runs, discover trends in the data that may require additional operator training, ensure correct completion of case report forms, and resolve queries quickly. At the end of the study, gather the study team to review and improve processes. Use the outcome to set expectations of other functional areas and to provide product feedback.